To evaluate the safety of rgp120/HIV-1MN vaccine in HIV-1 infected pregnant women with CD4 counts >= 400 cells/mm3. To evaluate the immunogenicity of this vaccine in pregnant women and the passive acquisition of vaccine-specific antibody in their infants. To evaluate the induction or augmentation by rgp120/HIV-1MN vaccine of mucosal immune response in the gastrointestinal and reproductive tracts during pregnancy. To isolate and genetically characterize the HIV-1 present in cervicovaginal fluid specimens of pregnant women and compare it to that present in their peripheral blood mononuclear cells and to that of their infected infants. Evidence suggests that an advanced stage of disease with high plasma viremia is associated with increased transmission of HIV-1 to the fetus. Slowing the progression of disease, reducing the titer of virus in plasma, and increasing the titer of epitope-specific antibody are potentially attainable goals through active immunization of the mother during pregnancy.

Condition	Treatment or Intervention	Phase
HIV Infections Pregnancy	Vaccine: rgp120/HIV-1MN	Phase I

Evidence suggests that an advanced stage of disease with high plasma viremia is associated with increased transmission of HIV-1 to the fetus. Slowing the progression of disease, reducing the titer of virus in plasma, and increasing the titer of epitope-specific antibody are potentially attainable goals through active immunization of the mother during pregnancy.

Pregnant women are randomized to receive an initial injection of MN rgp120 vaccine or alum placebo between week 16 and week 24 of gestation, followed by monthly booster injections concluding at the end of pregnancy, for a total of five injections. Patients may have optional booster immunizations (vaccine or placebo) at 3, 6, 9, and 12 months after delivery. Mothers and infants are followed through 18 months after delivery. Per 06/94 addendum, patients will be contacted once or twice per year for at least 5 years to check on health status of patient and child. PER 12/21/94 ADDENDUM, post-partum immunizations are discontinued.

Ages Eligible for Study:  16 Years   -   40 Years,  Genders Eligible for Study:  Female

Criteria

Inclusion Criteria

Concurrent Medication: Allowed:

• AZT.
• Acyclovir.

Patients must have:

• HIV-1 infection.
• CD4 count >= 400 cells/mm3.
• No AIDS-defining illness or other systemic manifestations related to HIV (other than generalized lymphadenopathy).
• HIV p24 < 30 pg/ml.
• Proven pregnancy in the 16th to 24th week of gestation at study entry, with no special obstetrical risks.
• Concurrent AZT therapy is permitted.

Exclusion Criteria

Co-existing Condition: Patients with the following symptoms and conditions are excluded:

• Known hypersensitivity to a component of the vaccine.
• Evidence of fetal abnormality on ultrasound.
• Evidence of maternal risk factors including insulin-dependent diabetes, moderate to severe hypertension, repeated fetal wastage (> 3), Rh-sensitization or other blood group alloimmunization, severe renal disease, previous infants with malformations or other factors that obstetrically are judged to constitute a special risk of spontaneous abortion or premature birth.
• Active syphilis.
• Hepatitis B surface antigen positive.

Concurrent Medication: Excluded:

• Antiretroviral or immunomodulating agent other than AZT during the pregnancy.

Prior Medication: Excluded:

• Antiretroviral or immunomodulating agent other than AZT within 90 days prior to study entry.

Current use of illicit drugs or known chronic alcohol use.

California
      San Francisco Gen Hosp, San Francisco,  California,  941102859,  United States
Maryland
      Johns Hopkins Hosp - Pediatric, Baltimore,  Maryland,  212874933,  United States
      Johns Hopkins Univ / School of Hygiene & Public Health, Baltimore,  Maryland,  212051901,  United States
Missouri
      St Louis Regional Hosp / St Louis Regional Med Ctr, St. Louis,  Missouri,  63112,  United States
      St Louis Univ School of Medicine, St. Louis,  Missouri,  63104,  United States
New York
      Univ of Rochester Med Ctr, Rochester,  New York,  14642,  United States
South Carolina
      Julio Arroyo, West Columbia,  South Carolina,  29169,  United States
Tennessee
      Vanderbilt Univ Hosp, Nashville,  Tennessee,  37232,  United States
Washington
      Children's Hosp of Seattle, Seattle,  Washington,  98105,  United States
      Univ of Washington / Pacific Med Ctr, Seattle,  Washington,  98144,  United States

Study chairs or principal investigators

Wara DW,  Study Chair
Lambert JS,  Study Chair
Wright PF,  Study Chair

Study ID Numbers:  ACTG 235; Aveg 104
Record last reviewed:  October 2002
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00001041
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-10-20